Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers
Study Details
Study Description
Brief Summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a phase I study to evaluate the safety, tolerability and effectiveness of TQB102 injection in subjects with advanced malignancies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQB2102 injection intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg) |
Drug: TQB2102 injection
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.
|
Outcome Measures
Primary Outcome Measures
- Dose Limiting Toxicity (DLT) [During the first treatment cycle (21 days).]
DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.
- Maximum tolerated dose (MTD) [During the first treatment cycle (21 days).]
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
- The occurrence rate of all adverse events (AEs) [From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.]
The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
- The severity of all adverse events (AEs) [From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first.]
The severity of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Secondary Outcome Measures
- Immunogenicity [Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days). 90 days after the end of the last infusion.]
Incidence of anti-drug antibody (ADA)
- Area under the curve (AUC) [Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days]
The area under the curve (AUC) of serum or plasma concentration of ADC drug, total antibody, and small molecule toxin.
- Peak concentration (Cmax) [Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 days]
Maximum observed concentration (Cmax) of ADC drug, total antibody, and small molecule toxin.
- Terminal half-life (T1/2) [Before infusion, 15 minutes after infusion on Cycle1 Day1, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1 and Cycle6 Day1; 4 hours, 7 hours, 7days and 14days after infusion on Cycle1 Day1; 4 hours and 7 hours after infusion on Cycle3 Day1. each cycle is 21 day]
Terminal plasma half-life is the time required to divide the plasma concentration by two.
- Objective Response Rate (ORR) [Baseline up to 2 years.]
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
- Disease control rate (DCR) [Baseline up to 2 years.]
Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).
- Duration of Response (DOR) [Baseline to the date of documented disease progression, up to 2 years.]
Defined as the time from first documented response to documented disease progression.
- Progression-free survival (PFS) [Baseline to the date of documented disease progression, up to 2 years.]
Defined as the time from first documented response to documented disease progression.
- Overall survival(OS) [Baseline to the date of death from any cause, up to 2 years.]
Overall survival refers to the time from the first treatment to death from any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
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Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
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Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
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Malignant tumor that failed from standard treatment or had no standard treatment;
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According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
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The main organs function well;
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Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
Exclusion Criteria:
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Concurrent secondary malignancy or other malignancy with no evidence of disease for more than 3 years;
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History of uncontrolled intercurrent illness;
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Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
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Patients with known symptomatic brain metastases;
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Receiving any other investigational agent within 4 weeks before first dose;
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Patients with severe hypersensitivity after the use of monoclonal antibodies
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History of interstitial lung disease or pneumonia;
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Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TQB2102-I-01